Effect of Massage on treatment of preterm feeding intolerance: Study protocol for a randomized controlled trial

Introduction: Feeding intolerance (FI) is a common neonatal disease, which may badly influence infants’ health. According to previous study, massage could prevent preterm feeding intolerance, promote maturation of gastrointestinal function and weight gain, but rarely used as an adjuvant treatment of feeding intolerance. This trial aims to evaluate the effectiveness of massage on treatment of FI. Method: The randomized controlled trial is to be conducted in Chongqing, China. 104 preterm infants whose gestational age between 28-34 weeks and birth weight between 1000g-2000g with diagnosis of feeding intolerance will be involved in the study. Participants will be stratified by birth weight (1000-1499g or 1500-2000g), and randomized to either the intervention group, who will receive massage twice a day for 7 days on the basis of routine treatment, or the control group, who will not receive any intervention except for routine treatment. Researchers blinding to group allocation will be maintained. Primary outcomes include the time from the initiation of enteral nutrition to total enteral nutrition. Secondary outcomes include duration of vomiting and abdominal distension(day), gastric residual volume, weight gain, change of length and head circumference during hospitalization, length of hospital stay (day), change of abdomen circumference（cm）, duration of diarrhea. Data will be collected in CRFs, and analyzed after data for the entire sample has been collected. Discussion: This study has the potential to provide evidence to inform that massage will improve feeding tolerance, growth and development as well as metabolism of body. This will enable us to develop a convenient and efficient way for curing preterm feeding intolerance, and improve infants’ long-term health outcomes. Trial registration: Chinese Clinical Trial Registry, ChiCTR2100045033, Registered on 3rd April 2021